The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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8326–8350 of 13731

  • HighFDA (Devices)·Z-0009-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip Guide Catheters because they were manufactured with an incorrect tip curve shape that differs from the labeled specification.

    Product
    Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2649-2023·2023-10-11

    Medline CirClamp Surgical Clamp Recalled for Incorrect Assembly

    Medline is recalling 106 units of Centurion Sterile CirClamp with 1.45cm bell due to kits containing an incorrect subassembly that results in incorrect bell and base size.

    Product
    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2650-2023·2023-10-11

    IceCure Cryoablation System ProSense Manual Updated for Mechanical Damage Safety

    Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.

    Product
    IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling certain lots of Guider Softip Guide Catheters due to an incorrect tip curve shape. The affected devices were distributed with a different tip curve than labeled.

    Product
    Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2024·2023-10-11

    VITROS Proboscis/Piston Assembly Recall for Assay Accuracy Defect

    Ortho-Clinical Diagnostics is recalling 9,860 Proboscis/Piston Assemblies for VITROS diagnostic systems manufactured April-December 2022 due to a manufacturing defect that may cause falsely elevated drug assay results and delayed patient test results.

    Product
    Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2024·2023-10-11

    Mass Spectrometer Recalled for Risk of Flame and Electrode Ejection

    AB Sciex is recalling 14 Citrine Triple Quad Mass Spectrometers (Part Number 5063684) due to rare risk of solvent leak and electrical discharge potentially causing flame and electrode ejection at the ion source probe.

    Product
    Citrine Triple Quad Mass Spectrometer, Part Number 5063684
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2024·2023-10-11

    BD Cathena IV Catheter Safety Shield May Fail to Properly Engage

    Becton Dickinson is recalling BD Cathena IV catheters because the safety shield may fail to properly engage, potentially exposing the contaminated needle.

    Product
    REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2024·2023-10-11

    Cardiac guide catheter recalled for incorrect tip curve shape

    Boston Scientific is recalling 1,728 units of Guider Softip Guide Catheter 6F due to a manufacturing defect producing incorrect tip curve shapes differing from labeled specifications.

    Product
    Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2665-2023·2023-10-11

    Qiagen therascreen KRAS PCR Kit Handbook Error Could Cause False Negative Results

    Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.

    Product
    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2663-2023·2023-10-11

    Veran Navigation System Biopsy Needle Devices: Electromagnetic Compatibility Issue

    Olympus is recalling 522 units of Veran navigation system biopsy needles due to manufacturing defects and insufficient electromagnetic compatibility testing. Devices may not function properly in certain electromagnetic environments.

    Product
    Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2024·2023-10-11

    Guide Catheter Recalled for Incorrect Tip Curve Shape

    Stryker Neurovascular identified that certain Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from the label. No injuries or illnesses have been reported.

    Product
    Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2023·2023-10-11

    Cuff Pressure Manager Power Inlet Dislodgment Prevents Charging

    The Puritan Bennett Cuff Pressure Manager's internal power inlet can become dislodged, preventing the device from charging. This may delay patient treatment.

    Product
    Puritan Bennett Cuff Pressure Manager, REF: 180-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0072-2024·2023-10-11

    Medical Device Recall: LFS Flat Screen Support Arm Bracket Failure

    The FDA is recalling LFS flat screen support arm systems because the stopper block could be broken or missing. Without this stopper, the screen can rotate excessively and damage the bracket's spring shaft.

    Product
    LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0012-2024·2023-10-11

    Cardiac guide catheters recalled for incorrect tip curve

    Boston Scientific is recalling Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from labeled specifications.

    Product
    Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2024·2023-10-11

    LFS flat screen arm system surgical lamp bracket stopper block defect

    The LFS flat screen arm system with surgical lamp has a broken or missing stopper block that could allow the screen to rotate excessively, potentially causing the spring shaft to break and shear off.

    Product
    LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFS
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0041-2024·2023-10-11

    Real Intelligence CORI knee surgery software missing planning stage

    Real Intelligence CORI RI.KNEE v2.0 surgical planning software is being recalled due to a missing planning stage in cases with significant knee deformation. Affected units nationwide should not be used without verification.

    Product
    Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2024·2023-10-11

    Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

    Boston Scientific is recalling 1004 units of Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from the labeled specifications.

    Product
    Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2653-2023·2023-10-11

    Apellis Injection Kit Filter Needles Recalled for Structural Defects

    Apellis Pharmaceuticals is recalling 61,943 units of Injection Kit components due to structural variations in the 19-gauge filter needle. No causal relationship has been established between the defect and the rare adverse events observed.

    Product
    Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2023·2023-10-11

    Olympus SPiN Thoracic Navigation System Models Recalled for EMC Non-Conformance

    Olympus is recalling SPiN Thoracic Navigation System and related models due to manufacturing non-conformances and insufficient electromagnetic compatibility (EMC) evidence. The devices may malfunction in certain electrical environments.

    Product
    Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2648-2023·2023-10-11

    Siemens MAGNETOM headphones may create artifacts during MRI imaging

    Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.

    Product
    (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 1140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2657-2023·2023-10-11

    Medtronic Restore Clinician Programmer software recalled for compatibility issue

    Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.

    Product
    Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2631-2023·2023-10-04

    Philips Respironics V60 and V60 Plus Ventilators Power Management Failure Recall

    Philips Respironics V60 and V60 Plus ventilators are recalled because their power management components may fail, causing complete loss of ventilator function. The FDA classified this as a Class I recall.

    Product
    Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2645-2023·2023-10-04

    Stryker Recalls Expired Cinchlock SS Knotless Anchor Inserter Units

    Stryker Corporation is recalling 96 units of the expired Cinchlock SS Knotless Anchor Inserter (Part Number CAT02462, Lot 19175AE2) distributed nationwide. Expired surgical devices may not perform reliably during use.

    Product
    Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2023·2023-10-04

    3M Attest Biological Indicator caps may fail during steam sterilization

    3M is recalling 79,500 Attest Super Rapid Readout Biological Indicators because the cap may melt, deform, or crack during steam sterilization cycles, potentially compromising sterilization validation.

    Product
    3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2641-2023·2023-10-04

    MobileLink Acetabular Cup System Recalled for Incorrect Offset Labeling

    Waldemar Link is recalling 8 units of the MobileLink Acetabular Cup System due to labeling with an incorrect offset specification. The mislabeling could affect proper surgical placement of this orthopedic implant.

    Product
    MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
    Category
    Medical Device
    Distribution
    3 states